| Primary Device ID | 04260636673443 |
| NIH Device Record Key | de123339-9693-4bfd-b966-4aeaeb6fba57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simmetry, Decorticator Blades |
| Version Model Number | BAT00110 |
| Company DUNS | 537619731 |
| Company Name | Paradigm Spine GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260636673443 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
[04260636673443]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-21 |
| Device Publish Date | 2020-07-13 |
| 04260636678998 - coflex instrument loaner set | 2023-04-10 instrument loaner set |
| 04260636678912 - CoFix instrument loaner set | 2021-06-29 |
| 04260636678929 - CoFix implant loaner set | 2021-06-29 |
| 04260636673467 - SImmetry, Blunt Pin, 3.2mm | 2021-02-02 |
| 04260636673474 - SImmetry, Impactor | 2021-02-02 |
| 04260636673481 - SImmetry, Long Pin, 3.2mm | 2021-02-02 |
| 04260636673498 - SImmetry, Short Pin, 3.2mm | 2021-02-02 |
| 04260636673504 - SImmetry, Working Cannula | 2021-02-02 |